Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the use of ustekinumab, followed by abatacept, will prevent relapse in people with moderate to severe plaque psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Abatacept; Immunoglobulins; Ustekinumab

Criteria

Inclusion Criteria:

• A diagnosis of plaque psoriasis for at least 6 months

• Baseline Psoriasis Area and Severity Index (PASI) score >= 12

• >=10% body surface area psoriasis involvement

• Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial

• Ability and willingness to provide informed consent and comply with study requirements

Exclusion Criteria:

• Non-plaque forms of psoriasis

• Grade 2 or 3 moderate to severe psoriatic arthritis not adequately managed with non-steroidal anti-inflammatory drugs (NSAIDs)

• Myocardial infarction, unstable angina, cerebrovascular accident, or other significant cardiovascular event within the previous one year

• Chronic obstructive pulmonary disease (COPD)

• Comorbid condition that requires regular systemic corticosteroid treatment

• History of malignancy, except treated basal cell skin carcinoma

• Treated basal cell skin carcinoma within the previous 5 years

• Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study

• History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections

• Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)

• Positive QuantiFERON-TB Gold test. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON-TB Gold test.

• Severe reaction or anaphylaxis to any human monoclonal antibody

• Any previous treatment with agents targeting Interleukin (IL)-12 or IL-23, including ustekinumab

• Any previous treatment with abatacept

• Treatment with biologic agents within previous 3 months, including adalimumab, etanercept, and infliximab

• Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks

• Topical psoriasis treatment within previous 2 weeks, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar

• Investigational study medication within previous 6 months

• Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are >/= 2x the upper limit of normal (ULN).

• Serum creatinine >= 2x the ULN.

• Any of the following hematologic abnormalities, confirmed by repeat test at least 1 week apart:

1. White blood count <3,000/μL or >14,000/μL;

2. Lymphocyte count <1,000/μL;

3. Neutrophil count <1,500/μL;

4. Platelet count <150,000 /μL; or

5. Hemoglobin <10 g/dL.

• Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use FDA-approved method of birth control

• Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the 6 weeks before enrollment

• BCG (Bacillus Calmette-Guérin) vaccine one year prior to enrollment